Methods and systems for treating seizures caused by brain stimulation

ABSTRACT

Methods for treating seizures caused by brain stimulation include providing a stimulator, programming the stimulator with one or more stimulation parameters configured to treat a medical condition, applying at least one stimulus with the stimulator to a stimulation site within the brain of a patient in accordance with the one or more stimulation parameters, and monitoring the patient for a seizure caused by the at least one stimulus.

RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.12/339,639, filed on Dec. 19, 2008, now issued as U.S. Pat. No. ______,which claims priority under 35 U.S.C. §119(e) to U.S. Provisional PatentApplication No. 61/016,642, filed on Dec. 26, 2007, the contents ofwhich are hereby incorporated by reference in their entirety.

BACKGROUND

Stimulation of the brain (e.g., deep brain stimulation) is often used totreat a variety of medical conditions including, but not limited to,Parkinson's disease, dystonia, essential tremor, epilepsy, obesity,depression, motor control disorders, and other debilitating diseases. Tofacilitate brain stimulation, a lead with one or more electrodesdisposed thereon may be strategically placed at a stimulation site inthe brain. Electrical stimulation generated by a stimulator may then beapplied to the stimulation site via one or more of the electrodes.

While brain stimulation has proven to be quite effective in treatingmany different medical conditions, a number of negative side effects areoften associated with the treatment. For example, brain stimulation mayactually cause generalized seizures, which can be detrimental to apatient and his or her safety, health, and well-being.

SUMMARY

Methods of treating seizures caused by brain stimulation includeproviding a stimulator, programming the stimulator with one or morestimulation parameters configured to treat a medical condition, applyingat least one stimulus with the stimulator to a stimulation site withinthe brain of a patient in accordance with the one or more stimulationparameters, and monitoring the patient for a seizure caused by the atleast one stimulus.

Systems for treating seizures caused by brain stimulation include astimulator configured to generate at least one stimulus in accordancewith one or more stimulation parameters adjusted to treat a medicalcondition, a programmable memory unit in communication with thestimulator and programmed to store the one or more stimulationparameters to at least partially define the stimulus such that thestimulus is configured to treat the medical condition, means forapplying the stimulus to a stimulation site within the brain of thepatient, and a monitoring unit that is a part of the stimulator andconfigured to monitor the patient for a seizure caused by the at leastone stimulus.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments of theprinciples described herein and are a part of the specification. Theillustrated embodiments are merely examples and do not limit the scopeof the disclosure.

FIG. 1 depicts an exemplary human brain.

FIG. 2 illustrates an exemplary implantable stimulator according toprinciples described herein.

FIG. 3 illustrates an exemplary microstimulator according to principlesdescribed herein.

FIG. 4A shows an example of a microstimulator with one or more leadscoupled thereto according to principles described herein.

FIG. 4B shows an example of a microstimulator with a plurality ofelectrodes disposed on an outer surface thereof according to principlesdescribed herein.

FIG. 4C shows the exemplary microstimulator of FIG. 4B coupled to a leadhaving a number of electrodes disposed thereon.

FIG. 5 depicts a number of stimulators configured to communicate witheach other and/or with one or more external devices according toprinciples described herein.

FIG. 6 is a flow chart illustrating an exemplary method of treating aseizure caused by brain stimulation according to principles describedherein.

FIGS. 7-8 illustrate exemplary configurations wherein one or moreelectrodes coupled to an implantable stimulator are in communicationwith one or more stimulation sites within the brain of a patientaccording to principles described herein.

Throughout the drawings, identical reference numbers designate similar,but not necessarily identical, elements.

DETAILED DESCRIPTION

Methods and systems for treating seizures caused by brain stimulationare described herein. A stimulator may be provided that is configured toapply at least one stimulus to the brain of a patient in order to treata particular medical condition. The stimulator may also be configured tomonitor the patient for an event associated with an impending or alreadyoccurring seizure that may occur as a result of the stimulus beingapplied to the brain. If the stimulator detects any such seizure, thestimulator is configured to treat the seizure. As used herein,“treating” a seizure caused by brain stimulation refers to any actionthat prevents a seizure from occurring, stops an already occurringseizure, reduces the severity of a seizure, and/or warns the patient ofan impending or already occurring seizure.

In the following description, for purposes of explanation, numerousspecific details are set forth in order to provide a thoroughunderstanding of the present systems and methods. It will be apparent,however, to one skilled in the art that the present systems and methodsmay be practiced without these specific details. Reference in thespecification to “one embodiment” or “an embodiment” means that aparticular feature, structure, or characteristic described in connectionwith the embodiment is included in at least one embodiment. Theappearance of the phrase “in one embodiment” in various places in thespecification are not necessarily all referring to the same embodiment.

FIG. 1 depicts an exemplary human brain 100. As mentioned, one or morestimulation sites within the brain 100 are often stimulated in order totreat a variety of medical conditions. In some examples, the stimulationis provided by a stimulator, which may be implanted within the patientor located external to the patient. As used herein, and in the appendedclaims, the term “stimulator” will be used broadly to refer to anydevice configured to deliver a stimulus to a stimulation site within thebrain. Thus, the term “stimulator” includes, but is not limited to, adeep brain stimulator, microstimulator, implantable pulse generator(IPG), spinal cord stimulator (SCS), external trial stimulator, systemcontrol unit, drug pump, or similar device.

A more detailed description of an exemplary stimulator and its operationwill now be given in connection with FIG. 2. FIG. 2 illustrates anexemplary stimulator 120 that may be used to apply a stimulus to astimulation site within a patient, e.g., an electrical stimulation ofthe stimulation site, an infusion of one or more drugs at thestimulation site, or both. The electrical stimulation function of thestimulator 120 will be described first, followed by an explanation ofthe possible drug delivery function of the stimulator 120. It will beunderstood, however, that the stimulator 120 may be configured toprovide only electrical stimulation, only drug stimulation, both typesof stimulation, or any other type of stimulation as best suits aparticular patient.

The exemplary stimulator 120 shown in FIG. 2 is configured to provideelectrical stimulation to one or more stimulation sites within a patientand may include at least one lead 121 coupled thereto. In some examples,the at least one lead 121 includes a number of electrodes 122 throughwhich electrical stimulation current may be applied by the stimulator120 to a stimulation site. It will be recognized that the at least onelead 121 may include any number of electrodes 122 arranged in anyconfiguration as best serves a particular application. In somealternative examples, as will be described in more detail below, thestimulator 120 is leadless.

As illustrated in FIG. 2, the stimulator 120 includes a number ofcomponents. It will be recognized that the stimulator 120 may includeadditional and/or alternative components as best serves a particularapplication. A power source 125 is configured to output voltage used tosupply the various components within the stimulator 120 with powerand/or to generate the power used for electrical stimulation. The powersource 125 may include a primary battery, a rechargeable battery (e.g.,a lithium-ion battery), a super capacitor, a nuclear battery, amechanical resonator, an infrared collector (receiving, e.g., infraredenergy through the skin), a thermally-powered energy source (where,e.g., memory-shaped alloys exposed to a minimal temperature differencegenerate power), a flexural powered energy source (where a flexiblesection subject to flexural forces is part of the stimulator), abioenergy power source (where a chemical reaction provides an energysource), a fuel cell, a bioelectrical cell (where two or more electrodesuse tissue-generated potentials and currents to capture energy andconvert it to usable power), an osmotic pressure pump (where mechanicalenergy is generated due to fluid ingress), or the like.

In some examples, the power source 125 may be recharged using anexternal charging system. One type of rechargeable power supply that maybe used is described in U.S. Pat. No. 6,596,439, which is incorporatedherein by reference in its entirety. Other battery constructiontechniques that may be used to make the power source 125 include thoseshown, e.g., in U.S. Pat. Nos. 6,280,873; 6,458,171; 6,605,383; and6,607,843, all of which are incorporated herein by reference in theirrespective entireties.

The stimulator 120 may also include a coil 128 configured to receiveand/or emit a magnetic field (also referred to as a radio frequency (RF)field) that is used to communicate with, or receive power from, one ormore external devices. Such communication and/or power transfer mayinclude, but is not limited to, transcutaneously receiving data from theexternal device, transmitting data to the external device, and/orreceiving power used to recharge the power source 125.

For example, an external battery charging system (EBCS) 111 may beprovided to generate power that is used to recharge the power source 125via any suitable communication link. Additional external devicesincluding, but not limited to, a hand held programmer (HHP) 115, aclinician programming system (CPS) 117, and/or a manufacturing anddiagnostic system (MDS) 113 may also be provided and configured toactivate, deactivate, program, and/or test the stimulator 120 via one ormore communication links. It will be recognized that the communicationlinks shown in FIG. 2 may each include any type of link used to transmitdata or energy, such as, but not limited to, an RF link, an infrared(IR) link, an optical link, a thermal link, or any other energy-couplinglink.

Additionally, if multiple external devices are used in the treatment ofa patient, there may be communication among those external devices, aswell as with the implanted stimulator 120. It will be recognized thatany suitable communication link may be used among the various devicesillustrated.

The external devices shown in FIG. 2 are merely illustrative of the manydifferent external devices that may be used in connection with thestimulator 120. Furthermore, it will be recognized that the functionsperformed by any two or more of the external devices shown in FIG. 2 maybe performed by a single external device.

The stimulator 120 may also include electrical circuitry 124 configuredto generate the electrical stimulation current that is delivered to astimulation site via one or more of the electrodes 122. For example, theelectrical circuitry 124 may include one or more processors, capacitors,integrated circuits, resistors, coils, and/or any other componentconfigured to generate electrical stimulation current.

Additionally, the exemplary stimulator 120 shown in FIG. 2 may beconfigured to provide drug stimulation to a patient by applying one ormore drugs at a stimulation site within the patient. To this end, a pump127 may also be included within the stimulator 120. The pump 127 isconfigured to store and dispense one or more drugs, for example, througha catheter 123. The catheter 123 is coupled at a proximal end to thestimulator 120 and may have an infusion outlet 129 for infusing dosagesof the one or more drugs at the stimulation site and/or at any othersite within the patient. In some embodiments, the stimulator 120 mayinclude multiple catheters 123 and/or pumps 127 for storing and infusingdosages of the one or more drugs at the stimulation site.

The stimulator 120 may also include a programmable memory unit 126configured to store one or more stimulation parameters. The stimulationparameters may include, but are not limited to, electrical stimulationparameters, drug stimulation parameters, and other types of stimulationparameters. The programmable memory unit 126 allows a patient,clinician, or other user of the stimulator 120 to adjust the stimulationparameters such that the stimulation applied by the stimulator 120 issafe and efficacious for treatment of a particular patient. Theprogrammable memory unit 126 may include any type of memory unit suchas, but not limited to, random access memory (RAM), static RAM (SRAM), ahard drive, or the like.

The electrical stimulation parameters may control various parameters ofthe stimulation current applied to a stimulation site including, but notlimited to, the frequency, pulse width, amplitude, waveform (e.g.,square or sinusoidal), electrode configuration (i.e., anode-cathodeassignment), burst pattern (e.g., continuous or intermittent), dutycycle or burst repeat interval, ramp on time, and ramp off time. Thedrug stimulation parameters may control various parameters including,but not limited to, the amount of drugs infused at the stimulation site,the rate of drug infusion, and the frequency of drug infusion. Forexample, the drug stimulation parameters may cause the drug infusionrate to be intermittent, continuous, or bolus.

Specific stimulation parameters may have different effects on differentmedical conditions. Thus, in some examples, the stimulation parametersmay be adjusted at any time throughout the treatment course as bestserves the particular patient being treated. It will be recognized thatany of the characteristics of the stimulation current, including, butnot limited to, the pulse shape, amplitude, pulse width, frequency,burst pattern (e.g., continuous or intermittent), duty cycle or burstrepeat interval, ramp on time, and ramp off time may be adjustedthroughout the course of treatment as best serves a particularapplication.

In some examples, the stimulator 120 may also include a monitoring unit105 configured to monitor the patient for one or more seizures that maybe caused by the stimulation applied by the stimulator 120 to the brain.As will be described in more detail below, the monitoring unit 105 maybe further configured to detect one or more events indicative of animpending seizure caused by the brain stimulation and/or an alreadyoccurring seizure being caused by the brain stimulation.

The monitoring unit 105 is communicatively coupled to the programmablememory unit 126 and/or any other component within the stimulator 120 sothat data acquired by the monitoring unit 105 may be used to adjust thestimulation parameters used to generate the stimulation applied by thestimulator 120. The monitoring unit 105 may include any combination ofhardware, software, and/or firmware as may serve a particularapplication.

In some examples, the stimulator 120 may also include an anti-seizureunit 106 configured to treat one or more seizures caused by the brainstimulation. Various methods of treating seizures caused by brainstimulation will be described in more detail below. The anti-seizureunit 106 may be communicatively coupled to the programmable memory unit126, the monitoring unit 105, and/or any other component within thestimulator 120 as may serve a particular application. The anti-seizureunit 106 may include any combination of hardware, software, and/orfirmware as may serve a particular application.

The stimulator 120 of FIG. 2 is illustrative of many types ofstimulators that may be used in accordance with the systems and methodsdescribed herein. For example, the stimulator 120 may include a deepbrain stimulator, an implantable pulse generator (IPG), a spinal cordstimulator (SCS), a drug pump, or any other type of implantable deviceconfigured to deliver a stimulus to a stimulation site within the brainof a patient. Exemplary deep brain stimulators suitable for use asdescribed herein include, but are not limited to, those disclosed inU.S. Pat. Nos. 5,938,688; 6,016,449; and 6,539,263. Exemplary IPGssuitable for use as described herein include, but are not limited to,those disclosed in U.S. Pat. Nos. 6,381,496, 6,553,263; and 6,760,626.Exemplary spinal cord stimulators suitable for use as described hereininclude, but are not limited to, those disclosed in U.S. Pat. Nos.5,501,703; 6,487,446; and 6,516,227. All of these listed patents areincorporated herein by reference in their respective entireties.

The stimulator 120 of FIG. 2 may alternatively include amicrostimulator, such as a BION® microstimulator (Advanced Bionics®Corporation, Valencia, Calif.). Various details associated with themanufacture, operation, and use of implantable microstimulators aredisclosed in U.S. Pat. Nos. 5,193,539; 5,193,540; 5,312,439; 6,185,452;6,164,284; 6,208,894; and 6,051,017. All of these listed patents areincorporated herein by reference in their respective entireties.

FIG. 3 illustrates an exemplary microstimulator 130 that may be used asthe stimulator 120 described herein. Other configurations of themicrostimulator 130 are possible, as shown in the above-referencedpatents and as described further below.

As shown in FIG. 3, the microstimulator 130 may include the power source125, the programmable memory 126, the electrical circuitry 124, the pump127, the monitoring unit 105, and the anti-seizure unit 106 described inconnection with FIG. 2. These components are housed within a capsule132. The capsule 132 may be a thin, elongated cylinder or any othershape as best serves a particular application. The shape of the capsule132 may be determined by the structure of the desired stimulation siteand the method of implantation. In some examples, the microstimulator130 may include two or more leadless electrodes 133 disposed on theouter surface thereof.

The external surfaces of the microstimulator 130 may advantageously becomposed of biocompatible materials. For example, the capsule 132 may bemade of glass, ceramic, metal, or any other material that provides ahermetic package that will exclude water vapor but permit passage ofelectromagnetic fields used to transmit data and/or power. Theelectrodes 133 may be made of a noble or refractory metal or compound,such as platinum, iridium, tantalum, titanium, titanium nitride, niobiumor alloys of any of these, in order to avoid corrosion or electrolysiswhich could damage the surrounding tissues and the device.

The microstimulator 130 may also include one or more infusion outlets131 configured to dispense one or more drugs directly at a stimulationsite. Alternatively, one or more catheters may be coupled to theinfusion outlets 131 to deliver the drug therapy to a treatment sitesome distance from the body of the microstimulator 130.

FIGS. 4A-4C show alternative configurations of a microstimulator 130. Itwill be recognized that the alternative configurations shown in FIGS.4A-4C are merely illustrative of the many possible configurations of amicrostimulator 130. For example, FIG. 4A shows an example of amicrostimulator 130 with one or more leads 140 coupled thereto. As shownin FIG. 4A, each of the leads 140 may include one or more electrodes 141disposed thereon. The microstimulator 130 of FIG. 4A may additionally oralternatively include one or more leadless electrodes 133 disposed onthe outer surface thereof.

FIG. 4B illustrates an exemplary microstimulator 130 with a plurality ofelectrodes 133 disposed on an outer surface thereof. In some examples,any number of electrodes 133 may be disposed on the outer surface of themicrostimulator 130. In some alternative examples, as shown in FIG. 4C,the microstimulator 130 may be coupled to a lead 121 having a number ofelectrodes 122 disposed thereon. Each of the electrodes 133 and 122 maybe selectively configured to serve as an anode or as a cathode.

In some examples, the stimulator 120 of FIG. 2 may be configured tooperate independently. Alternatively, as shown in FIG. 5, the stimulator120 may be configured to operate in a coordinated manner with one ormore additional stimulators, other implanted devices, or other devicesexternal to the patient's body. FIG. 5 illustrates an exemplaryconfiguration wherein a first stimulator 120-1 implanted within thepatient 151 provides a stimulus to a first location, a second stimulator120-2 provides a stimulus to a second location, and a third stimulator120-3 provides a stimulus to a third location. In some examples, one ormore external devices 150 may be configured to control the operation ofeach of the implanted devices 120. In some embodiments, an implanteddevice, e.g., stimulator 120-1, may control, or operate under thecontrol of, another implanted device(s), e.g., stimulator 120-2 and/orstimulator 120-3. Control lines 152 have been drawn in FIG. 5 toillustrate that the external device 150 may communicate or provide powerto any of the implanted devices 120 and that each of the variousimplanted devices 120 may communicate with and, in some instances,control any of the other implanted devices.

As a further example of multiple stimulators 120 operating in acoordinated manner, the first and second stimulators 120-1 and 120-2 ofFIG. 5 may be configured to sense various indicators of a medicalcondition being treated and transmit the measured information to thethird stimulator 120-3. The third stimulator 120-3 may then use themeasured information to adjust its stimulation parameters and applystimulation to a stimulation site accordingly. The various implantedstimulators may, in any combination, sense indicators of the medicalcondition, communicate or receive data regarding such indicators, andadjust stimulation parameters accordingly.

In order to determine the strength and/or duration of electricalstimulation and/or amount and/or type(s) of stimulating drug(s) requiredto most effectively treat a particular medical condition, variousindicators of the medical condition and/or a patient's response totreatment may be sensed or measured. The stimulator 120 may then adjustthe stimulation parameters (e.g., in a closed loop manner) in responseto one or more of the sensed indicators. Exemplary indicators include,but are not limited to, electrical activity of the brain (e.g., EEG),neurotransmitter levels, patient input, ocular motility test results,and/or other eye examination test results. In some examples, thestimulator 120 may be configured to perform one or more of themeasurements. Alternatively, other sensing devices may be configured toperform the measurements and transmit the measured values to thestimulator 120.

Thus, one or more external devices may be provided to interact with thestimulator 120, and may be used to accomplish at least one or more ofthe following functions:

Function 1: If necessary, transmit electrical power to the stimulator120 in order to power the stimulator 120 and/or recharge the powersource 125.

Function 2: Transmit data to the stimulator 120 in order to change thestimulation parameters used by the stimulator 120.

Function 3: Receive data indicating the state of the stimulator 120(e.g., battery level, drug level, stimulation parameters, etc.).

Additional functions may include adjusting the stimulation parametersbased on information sensed by the stimulator 120 or by other sensingdevices.

As mentioned, each of the stimulators described herein may be used toapply a stimulus to a stimulation site within the brain in order totreat one or more of a variety of medical conditions. However, duringthe course of treatment, the stimulus applied by a stimulator may causethe patient to experience one or more seizures. Additionally oralternatively, seizures may be a side effect of the implant procedureused to implant one or more stimulating devices (e.g., the stimulator,lead(s), and/or catheter(s)) within the patient.

Hence, in some examples, a stimulator 120 may be configured to detectand treat seizures caused by brain stimulation and/or the implantationof one or more stimulating devices. Various stimulator configurationsfor detecting a seizure caused by brain stimulation will first bedescribed, followed by a discussion of various configurations that maybe used to treat a detected seizure.

In some examples, the stimulator 120 may be configured to detect anonset of a seizure caused by brain stimulation before the seizureactually occurs. For example, electrical activity within a normallyfunctioning brain can be measured as asynchronous brain waves thatfluctuate slightly with no particular pattern. However, prior to anonset of a seizure caused by brain stimulation, these brain waves maybecome synchronous or include some other signature electric pulse.

To this end, the stimulator 120 may be configured to monitor brain wavesby sensing electrical activity within the brain with one or moreelectrodes. The brain waves may be monitored during a stimulationtherapy session or at any other time as may serve a particularapplication. Moreover, the stimulator 120 may be configured to monitorthe brain waves continuously, intermittently, or on demand. When thestimulator 120 detects a brain wave indicative of an impending seizure(e.g., when the stimulator 120 detects synchronous brain waves), thestimulator 120 may be configured to perform an action configured toprevent, disrupt, or otherwise treat the impending seizure.

In some examples, one or more of the electrodes 122 describedhereinabove may be configured to monitor brain waves by sensingelectrical activity within the brain. Additionally or alternatively, oneor more electrodes dedicated to sensing electrical activity of the brainmay be coupled to the stimulator 120 and configured to sense electricalactivity of the brain. As will be described in more detail below, thededicated sensing electrodes may be disposed on a distinct lead 121.

In some examples, the sensing electrodes may be implanted at anysuitable site within the brain. For example, the sensing electrodes maybe implanted such that they are in communication with the cortex, thestimulation site being treated, or any other site within the brain.Additionally or alternatively, the sensing electrodes may be configuredto be located externally and monitor brain waves transcutaneously.

Additionally or alternatively, the stimulator 120 may be configured todetect a seizure caused by brain stimulation by detecting a change in aconcentration of one or more substances within the patient that havebeen shown to reveal the onset of seizures. These substances include,but are not limited to, glycogen, glucose, glutamate, aspartate,phosphocreatine, and potassium.

To this end, the stimulator 120 may include and/or be in communicationwith a sensor configured to detect changes in concentrations ofsubstances that are indicative of an impending seizure. In someexamples, if the stimulator 120 detects an increase in concentration ofone or more of these substances above a programmable threshold, thestimulator may be configured to perform an action configured to prevent,disrupt, or otherwise treat the impending seizure. Additionally oralternatively, if the stimulator 120 detects a decrease in concentrationof one or more of these substances below a programmable threshold, thestimulator 120 may be configured to perform an action configured toprevent, disrupt, or otherwise treat the impending seizure.

Additionally or alternatively, the stimulator 120 may be configured todetect a seizure caused by brain stimulation by detecting movementpatterns of the patient that are associated with a seizure. Movementpatterns associated with an impending seizure include, but are notlimited to, spasms, sudden movements, and tremors. To this end, thestimulator 120 may include and/or be in communication with one or moreaccelerometers and/or other movement sensors. If the stimulator 120detects a movement pattern indicative of an impending seizure, thestimulator 120 may be configured to perform an action configured toprevent, disrupt, or otherwise treat the impending seizure.

Additionally or alternatively, the stimulator 120 may be configured todetect a seizure caused by brain stimulation by monitoring patient inputor feedback. In many instances, a patient can sense that he or she isabout to experience a seizure as a result of brain stimulation. To thisend, the patient may communicate to the stimulator 120 the presence ofan impending seizure. Upon receiving this communication, the stimulator120 may be configured to perform an action configured to prevent,disrupt, or otherwise treat the impending seizure. In some examples, thepatient may communicate with the stimulator 120 via one or moreprogramming devices, remote controls, or other external devicescommunicatively coupled to the stimulator 120.

As mentioned, once the stimulator 120 has detected a seizure caused bybrain stimulation (which may be impending or actually occurring), thestimulator 120 may treat the seizure in a variety of different manners.For example, as will be described in more detail below, the stimulator120 may prevent, stop, disrupt, reduce the severity of, and/or warn thepatient of the seizure.

In some examples, the stimulator 120 may be configured to treat a sensedseizure by adjusting the stimulation parameters that control thestimulation being applied by the stimulator 120 to the brain. Forexample, the frequency, pulse width, amplitude, and/or any othercharacteristic of electrical stimulation being applied to the brain bythe stimulator 120 may be adjusted in accordance with pre-programmedstimulation algorithms configured to treat seizures.

Additionally or alternatively, the stimulator 120 may be configured toswitch from synchronous electrical stimulation to asynchronouselectrical stimulation when a seizure is detected. It is believed thatasynchronous electrical stimulation may be effective in disrupting thesynchronous brain waves that are often associated with the occurrence ofa seizure. Hence, application of asynchronous electrical stimulation bythe stimulator 120 to the brain may be effective in treating a seizurecaused by brain stimulation.

Additionally or alternatively, the stimulator 120 may be configured tostop applying stimulation to the brain when a seizure is detected. Tothis end, the stimulator 120 may include a switch or other shut-offmechanism configured to turn off stimulation being applied to the brainwhen the stimulator 120 detects a seizure. In some examples, theshut-off mechanism may be controlled by an external device operable bythe patient. In this manner, the patient may invoke a command configuredto activate the shut-off mechanism via the external device when thepatient feels the onset of a seizure.

Additionally or alternatively, the stimulator 120 may be configured totreat a sensed seizure caused by brain stimulation by activatinginhibitory pathways within the brain. For example, the stimulator 120may be configured to infuse an inhibitory substance (e.g., GABA,dopamine, and/or other neurotransmitters) into the brain. It is believedthat activation of inhibitory pathways within the brain may be useful inpreventing, disrupting or otherwise alleviating a seizure caused bybrain stimulation.

In some examples, the stimulator 120 may additionally or alternativelybe configured to warn a patient of a seizure caused by brain stimulationvia an alarm. The alarm may be a part of an external device worn orotherwise accessed by the user. For example, the alarm may be includedwithin a remote control, external programming device, pager, mobiletelephone, personal computer, or any other external device configured tobe communicatively coupled to the stimulator 120. The alarm may includean audio signal, a vibration, a visual display, and/or any other featureconfigured to alert the patient of the presence of a seizure. Thestimulator 120 may be configured to communicate with the alarm using anysuitable communication link as described hereinabove in connection withFIG. 2.

By way of example, an exemplary method of treating a seizure caused bybrain stimulation may be carried out according to the steps shown in theflow chart of FIG. 6. The steps shown in FIG. 6 may be modified,reordered, and/or added to as may serve a particular application.

In step 160, a stimulator 120 is implanted so that its electrodes and/orinfusion outlet are in communication with a stimulation site within thebrain of a patient. As used herein and in the appended claims, the term“in communication with” refers to the stimulator, stimulatingelectrodes, and/or infusion outlet being adjacent to, in the generalvicinity of, in close proximity to, directly next to, or directly on thestimulation site. In some alternative examples, the stimulator islocated external to the patient.

In step 161, one or more stimulation parameters are configured to treata medical condition. The stimulator may then be programmed with the oneor more stimulation parameters configured to treat the medicalcondition, as shown in step 162. The stimulator may then generate andapply at least one stimulus to the stimulation site within the brain inaccordance with the stimulation parameters, as shown in step 163. Thestimulus may include electrical stimulation, drug stimulation, geneinfusion, chemical stimulation, thermal stimulation, electromagneticstimulation, mechanical stimulation, and/or any other suitablestimulation.

During the course of the brain stimulation treatment, the stimulatormonitors the patient for any event or occurrence indicative of animpending or already occurring seizure that may occur as a result of thebrain stimulation (step 164). For example, the stimulator may beconfigured to sense one or more brain waves indicative of a seizure,detect a change in concentration of one or more substances indicative ofa seizure, detect movement patterns indicative of a seizure, and/ormonitor patient feedback indicative of a seizure.

If a seizure is detected by the stimulator, the stimulator treats theseizure, as shown in step 166. The seizure may be treated by adjustingthe stimulation parameters, applying an asynchronous electricalstimulation pulse to one or more locations within the brain, stoppingthe stimulation, activating inhibitory pathways within the brain,warning the patient of the seizure, and/or performing any other functionas may serve a particular application.

The stimulator may be implanted within a patient using any suitablesurgical procedure such as, but not limited to, small incision, openplacement, laparoscopy, or endoscopy. Exemplary methods of implanting adeep brain stimulator, for example, are described in U.S. Pat. Nos.7,938,688; 6,016,449; and 6,539,263. Exemplary methods of implanting amicrostimulator, for example, are described in U.S. Pat. Nos. 7,193,539;5,193,540; 5,312,439; 6,185,452; 6,164,284; 6,208,894; and 6,051,017.Exemplary methods of implanting an SCS, for example, are described inU.S. Pat. Nos. 7,501,703; 6,487,446; and 6,516,227. All of these listedpatents are incorporated herein by reference in their respectiveentireties.

To illustrate, FIGS. 7-8 illustrate exemplary configurations wherein oneor more electrodes 122 coupled to an implantable stimulator 120 are incommunication with one or more stimulation sites within the brain. Theconfigurations shown in FIGS. 7-8 are merely illustrative of the manydifferent implant configurations that may be used in accordance with thesystems and methods described herein.

For example, as shown in FIG. 7, the stimulator 120 may be implantedbeneath the scalp, such as in a surgically-created shallow depression oropening in the skull. The surgically-created shallow depression oropening may be located in the parietal bone 171, the temporal bone 172,and/or the frontal bone 173. In some examples, the stimulator 120 isconfigured to conform to the profile of surrounding tissue(s) and/orbone(s). This may minimize pressure applied to the skin or scalp, whichpressure may result in skin erosion or infection.

As shown in FIG. 7, first and second leads 121-1 and 121-2,respectively, may be coupled to the stimulator 120. In some examples,the first lead 121-1 includes one or more electrodes 122-1 disposedthereon that are configured to apply electrical stimulation to one ormore stimulation sites within the brain. The second lead 121-2 mayinclude one or more electrodes 122-2 disposed thereon that areconfigured to monitor for the occurrence of a seizure by sensingelectrical activity of the brain. As shown in FIG. 7, the stimulatingelectrodes 122-1 and the sensing electrodes 122-2 may be implanted indistinct areas of the brain. It will be recognized that any number ofleads 121 may be coupled to the stimulator 120 and implanted at anysuitable location within the brain. It will also be recognized that eachlead 121 may include any combination of stimulating and sensingelectrodes.

Alternatively, as shown in the cross-sectional view of FIG. 8, thestimulator 120 may be implanted within the lumen of a hole 180 createdin the skull 181 and configured to apply a stimulus at a stimulationsite within the brain. The hole 180 may be a burr hole, for example, andmay be created with a surgical drill or any other suitable device. Thehole 180 extends at least partially into the skull 181, and, as shown inFIG. 8, may extend all the way through the skull 181 until the hole 180is in communication with the outermost layer 182 of the brain. Thestimulator 120 is placed within the lumen of the hole 180 and coupled tothe walls of the hole 180 and/or the top surface of the outermost layer182 of the brain using an adhesive, suture, or any other fasteningdevice. Once the stimulator 120 has been implanted, the hole 180 may becovered by an appropriately sized cap (not shown).

As shown in FIG. 8, a lead 121 may be coupled to the stimulator 120 withthe distal end of the lead 121 being routed to a particular location incommunication with a stimulation site within the brain. A distal potionof the lead 121 may include one or more electrodes 122 configured todeliver an electrical stimulation current to the stimulation site. Oneor more of the electrodes 122 may additionally or alternatively beconfigured to monitor the brain for indicators of seizures caused bybrain stimulation. A catheter (not shown) may additionally oralternatively be coupled to the stimulator 120 and routed to thestimulation site so as to deliver one or more drugs at the stimulationsite.

In some alternative examples, a distal portion of the lead 121 may beplaced within the brain through a burr hole created within the skull. Aproximal portion of the lead 121 may exit the burr hole and be routed toan implant site of the stimulator 120 (e.g., a subcutaneous pocket madewithin the chest).

The preceding description has been presented only to illustrate anddescribe embodiments of the invention. It is not intended to beexhaustive or to limit the invention to any precise form disclosed. Manymodifications and variations are possible in light of the aboveteaching.

What is claimed is:
 1. A method comprising: providing a stimulator;programming said stimulator with one or more stimulation parametersconfigured to treat a medical condition; applying at least one stimuluswith said stimulator to a stimulation site within the brain of a patientin accordance with said one or more stimulation parameters; andmonitoring said patient for a seizure caused by said at least onestimulus.